肠膜对 pantoprazole 胃耐药仿制药片药物释放延迟的影响
Mosab Arafat1, Molham Sakkal1, Mohammad F Bostanudin1
1College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, 64141, United Arab Emirates.
F1000Research
|April 10, 2024
概括
通用潘托普拉 (PNZ) 片显示药物因肠道涂层变异而过早释放. 品牌产品是一个品牌产品.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 材料科学 材料科学 材料科学
背景情况:
- 肠道涂层保护酸性药物免受胃酸的影响.
- 涂料配方中的辅助剂变化可能会影响保护功能.
- 本研究检查了通用药片潘托普拉 (PNZ) 在市场上销售后召回后对肠道涂层的影响.
研究的目的:
- 调查涂层材料对PNZ通用药片肠膜功能的影响.
- 为了比较通用与品牌PNZ产品中的肠道涂层的保护性能.
- 确定与肠道涂层完整性相关的市场召回的潜在原因.
主要方法:
- 在不同pH值下进行的比较体外药物释放研究.
- 分析技术:DSC,TGA,XRD,SEM,FTIR,共聚焦拉曼显微镜.
- 清洁药物粉末的识别用于比较分析.
主要成果:
- 通用PNZ在酸性介质中表现出显著的体外药物释放变化.
- 在通用和品牌产品之间观察到XRD峰值强度和SEM粒子大小的差异.
- 斯佩克特分析表明,仿制品的涂层中存在潜在的杂质和变异.
结论:
- 通用PNZ肠道涂层中的辅助剂损害了其保护功能.
- 品牌产品的肠道涂层,可能增强了聚酸盐80,提供了优越的保护.
- 涂层材料的质量对于酸性药物配方的有效性至关重要.
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